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FDA 510(k)

ICONN Square 2.5MM Suture Anchor

K-Number: K172491 · 2017-11-29

ApplicantIconn Orthopedics, LLC
Decision Date2017-11-29
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ICONN Square 2.5MM Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Iconn Orthopedics, LLC. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K172491. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ICONN Square 2.5MM Suture Anchor?

ICONN Square 2.5MM Suture Anchor is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Iconn Orthopedics, LLC. The 510(k) number is K172491.

When did ICONN Square 2.5MM Suture Anchor receive FDA 510(k) clearance?

ICONN Square 2.5MM Suture Anchor received FDA 510(k) clearance on 2017-11-29, under 510(k) number K172491.

Who is the listed applicant for ICONN Square 2.5MM Suture Anchor?

The FDA 510(k) record lists Iconn Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICONN Square 2.5MM Suture Anchor?

The FDA product code for ICONN Square 2.5MM Suture Anchor is MBI.

Other records listing Iconn Orthopedics, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180670ICONN Campbell Interference ScrewK182264ICONN Revolution Knotless Suture AnchorK181680ICONN Answer II Suture Anchor

Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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